Sorry, you need to enable JavaScript to visit this website.
Skip to main content

Errata - English

PDF CSV November 24, 2022 through November 24, 2024 All Errata for USP–NF How to use
Enter the title of the monograph
Monograph Title Section Source Publication Page Number Errata Official Date Target Errata Print Publication Target Online Fix Publication Description
STERILE WATER FOR INHALATION CHEMICAL INFORMATION USP37–NF32 5174 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
STERILE WATER FOR IRRIGATION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5175 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add:
USP 1,4-Benzoquinone RS
AND
USP Sucrose RS
ETHYLCELLULOSE DISPERSION TYPE B ASSAY/Procedure USP37–NF32 5981 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 3 of Analysis: Change
Calculate the percentage of ethylcellulose in the portion of Ethylcellulose Dispersion Type B taken:
to:
Calculate the percentage of the labeled amount of ethylcellulose in the portion of Ethylcellulose Dispersion Type B taken:
CALCIUM GLUCONATE INJECTION Identification USP37–NF32 2089 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Identification test A: Change
A volume of Injection diluted, if necessary, with water to obtain a test solution of calcium gluconate (1 in 100) responds to Identification test B under Calcium Gluconate.
to:
Dissolve a quantity of it in water to… Read More
IRINOTECAN HYDROCHLORIDE INJECTION IMPURITIES/Organic Impurities USP37–NF32 3403 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Row 3 of Column 1 of Table 2: Change
Camptothecinb
to:
Camptothecinb,d
AND
Row 5 of Column 1: Change
7-Ethylcamptothecinc
to:
7-Ethylcamptothecinc,d
AND
Add a footnote:
dThese process impuritiesare… Read More
WATER FOR HEMODIALYSIS CHEMICAL INFORMATION USP37–NF32 5173 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
STERILE WATER FOR INJECTION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5175 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add:
USP 1,4-Benzoquinone RS
AND
USP Sucrose RS
CELLACEFATE ASSAY/Content of Acetyl USP37–NF32 5919 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 12 of Analysis:
Result = {[(P − 0.5182 × B)/(100 − B)] − (0.5772 × C)} × 100
to:
Result = 100 × [P − (0.5182 × B)]/(100 − B) − (0.5772 × C)
DACARBAZINE FOR INJECTION IMPURITIES/Limit of 2-Azahypoxanthine Second Supplement to USP37–NF32 Online 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 2 of Analysis: Change
2-azahypoxanthine monohydrate
to:
2-azahypoxanthine
DIDANOSINE DELAYED-RELEASE CAPSULES PERFORMANCE TESTS/Dissolution <711>/Analysis USP37–NF32 2603 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 11 of the variable definition list: Change
CS = concentration of didanosine in the Standard solution (mg/mL)
to:
CS = concentration of USP Didanosine Related Compound A RS in the Standard solution for the Acid stage or… Read More
OXYBUTYNIN CHLORIDE SPECIFIC TESTS/Loss on Drying <731> USP37–NF32 4129 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Acceptance criteria: Change
NMT 3.0%
to:
NMT 3%
STERILE WATER FOR INHALATION ADDITIONAL REQUIREMENTS/USP Reference Standards <11> USP37–NF32 5174 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add:
USP 1,4-Benzoquinone RS
AND
USP Sucrose RS
PURE STEAM CHEMICAL INFORMATION USP37–NF32 5176 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
CHLORPHENIRAMINE MALEATE IMPURITIES/Organic Impurities First Supplement to USP37–NF32 6617 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Standard solution: Change
1.1 μg/mL of USP Chlorpheniramine Maleate RS in Diluent,
to:
1.4 μg/mL of USP Chlorpheniramine Maleate RS in Diluent,
DACARBAZINE USP Reference standards <11> USP37–NF32 2504 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 3 of USP Dacarbazine Related Compound B RS: Change
C4H3N5O 137.10
to:
C4H3N5O · H2O 155.12
KETOPROFEN EXTENDED-RELEASE CAPSULES ASSAY/Procedure/System suitability/Suitability requirements USP37–NF32 3469 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Tailing factor: Change
NLT 1.5
to:
NMT 1.5
WATER FOR INJECTION CHEMICAL INFORMATION USP37–NF32 5173 1-Oct-2014 USP39–NF34 First Supplement to USP38–NF33 Add the chemical formula and molecular weight:
H2O 18.02
TICLOPIDINE HYDROCHLORIDE IMPURITIES USP37–NF32 4958 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Change
Residue on Ignition <231>
to:
Residue on Ignition <281>
ATROPINE SULFATE ASSAY/Procedure/System suitability/Suitability requirements First Supplement to USP37–NF32 6591 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1of Relative standard deviation: Change
NMT 1.0
to:
NMT 1.0%
<795> PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS DEFINITIONS USP37–NF32 403 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Beyond-Use Date (BUD): Change
The date after which a compounded preparation should not to be used;
to:
The date after which a compounded preparation shall not be used;
TERBINAFINE HYDROCHLORIDE IMPURITIES First Supplement to USP37–NF32 6704 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Footnotes b, c, and d of Table 2: Change
btrans-Isoterbinafine or (E)-N,6,6-trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine.
ccis-Terbinafine or (Z)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-… Read More
CEFAZOLIN INJECTION Assay USP37–NF32 2190 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Change
pH 3.6 Buffer, pH 7.0 Buffer, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Cefazolin.
to:
pH 3.6 Buffer—Dissolve 0.900 g of anhydrous… Read More
CLOPIDOGREL BISULFATE ASSAY/Procedure USP37–NF32 2422 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of System suitability solution: Change
25 µg/mL of USP Clopidogrel Bisulfate RS and 50 µg/mL of USP Clopidogrel Related Compound B RS
to:
2.5 µg/mL of USP Clopidogrel Bisulfate RS and 5.0 µg/mL of USP Clopidogrel Related Compound B RS
FLAVOXATE HYDROCHLORIDE IMPURITIES USP37–NF32 2988 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Row 3 of Column 1 of Impurity Table 1: Change
Flavoxate related compound Aa,*
to:
Flavoxate related compound Aa
AND
Row 4 of Column 1 of Impurity Table 1: Change
Flavoxate related compound Bb,*
to:
Flavoxate related compound B… Read More
MITOTANE TABLETS Assay USP37–NF32 3858 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Procedure: Change
Proceed as directed in the Assay under Mitotane, beginning with “Concomitantly determine the absorbances of both solutions.”
to:
Concomitantly determine the absorbances of the Assay preparation and the Standard preparationRead More
GELATIN SPECIFIC TESTS/Sulfur Dioxide/Analysis USP37–NF32 5995 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 5 of the variable definition list: Change
m = actual molarity of the Titrant (mol/mL)
to:
m = actual molarity of the Titrant (mol/L)
INSULIN ASPART IDENTIFICATION/B. Physicochemical Analytical Procedures for Insulins, Peptide Mapping <121.1>/Chromatographic system First Supplement to USP37–NF32 6647 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Column: Change
4.0-mm × 25-cm; 5-µm packing L7
to:
4.6-mm × 10-cm; 3-μm packing L1
AMIFOSTINE ASSAY/Procedure/System suitability/Suitability requirements USP37–NF32 1717 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Column efficiency: Change
NLT 100
to:
NLT 1000
TIZANIDINE TABLETS ASSAY/Procedure/System suitability Second Supplement to USP37–NF32 Online 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Change
Sample: Standard solution
to:
Samples: System suitability solution and Standard solution
AND
Change
Resolution: NLT 4.0 between tizanidine and tizanidine related compound C; NLT 4.0 between tizanidine and tizanidine related compound… Read More
CEFUROXIME FOR INJECTION Constituted solution USP37–NF32 2246 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 3: Change
meets the requirements for Constituted Solutions under Labeling under Injections <1>.
to:
meets the requirements for Constituted Solutions under Injections <1>.
DULOXETINE DELAYED-RELEASE CAPSULES IDENTIFICATION USP37–NF32 2743 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Change
A. Infrared Absorption <197S>
to:
A. Infrared Absorption <197F>
LEVODOPA IMPURITIES USP37–NF32 3533 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Row 6 of Column 1 of Table 1: Change
1-Veratrylglycine
to:
L-Veratrylglycinea
AND
Add a footnote:
a3-(3,4-Dimethoxyphenyl)-L-alanine.
VINBLASTINE SULFATE IDENTIFICATION/B. USP37–NF32 5150 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Sample: Change
100 mg/mL in water
to:
10 mg/mL in water
CEFADROXIL ASSAY/Procedure First Supplement to USP37–NF32 6602 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 3 of Sample solution: Change
USP Cefadroxil RS
to:
Cefadroxil
<1788> METHODS FOR THE DETERMINATION OF PARTICULATE MATTER IN INJECTIONS AND OPHTHALMIC SOLUTIONS LIGHT OBSCURATION PARTICLE COUNT TEST/Instrument Standardization Tests/Particle Counting Accuracy—System Suitability USP37–NF32 1301 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 26 of Method 1—MWHC Instruments: Change
PB is the average particle count obtained from the suspension;
to:
PS is the average particle count obtained from the suspension;
TERBINAFINE HYDROCHLORIDE ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP37–NF32 6704 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 2 of USP Terbinafine Related Compound A RS: Change
N-Methyl-C-(naphthalen-1-yl)methanamine.
to:
N-Methyl-C-(naphthalen-1-yl)methanamine hydrochloride.
AND
Line 2 of USP Terbinafine Related Compound B RS: Change
(2Z)-N,6,6-Trimethyl-… Read More
CEFTIZOXIME FOR INJECTION Constituted solution USP37–NF32 2240 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1: Change
At the time of use, it meets the requirements for Constituted Solutions under Labeling under Injections <1>.
to:
At the time of use, it meets the requirements for Constituted Solutions under Injections <1>.
DOXAPRAM HYDROCHLORIDE INJECTION ASSAY/Procedure USP37–NF32 2708 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 7 of Analysis: Change
RU = peak response ratio of the doxapram to the internal standard from the Sample solution
RS = peak response ratio of the doxapram to the internal standard from the Sample solution
to:
RU… Read More
LEFLUNOMIDE IMPURITIES/Organic Impurities/Procedure 2 USP37–NF32 3502 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 3 of Analysis: Change
[Note—Disregard any peak with an area less than the leflunomide peak from the System suitability solution.
to:
[Note—Disregard any peak with an area less than the leflunomide peak from the Sensitivity solution.
NALTREXONE HYDROCHLORIDE Assay USP37–NF32 3922 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 7 of Procedure: Change
(377.86/341.41)10C(rU/rS)
in which 377.86 and 341.41 are the molecular weights of naltrexone hydrochloride and naltrexone
to:
(377.86/341.40)10C(rU/r Read More
<551> VITAMIN E ASSAY ASSAY/Procedure 4/Chromatographic system First Supplement to USP37–NF32 6338 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Flow rate: Change
1.5 mL/min
to:
1 mL/min
GENERAL NOTICES TO USP-NF 6. TESTING PRACTICES AND PROCEDURES/6.50. Preparation of Solutions First Supplement to USP37–NF32 6291 1-Aug-2014 USP38–NF33 USP38–NF33 Line 6 of 6.50.20. Solutions: Change
An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2… Read More
SUFENTANIL CITRATE ASSAY/Procedure/System suitability/Suitability requirements First Supplement to USP37–NF32 6701 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Relative standard deviation: Change
NMT 0.7%
to:
NMT 0.73%
BUMETANIDE IMPURITIES USP37–NF32 2024 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Row 4 of Column 1 of Table 1: Change
Paroxetine butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate
to:
Butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate
ROPINIROLE HYDROCHLORIDE IMPURITIES/Organic Impurities, Procedure 1/System suitability/Suitability requirements Revision Bulletin (Official May 01, 2014) Online 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Tailing factor: Change
NLT 2.0 for the ropinirole peak
to:
NMT 2.0 for the ropinirole peak
CHLORDIAZEPOXIDE HYDROCHLORIDE FOR INJECTION Constituted solution USP37–NF32 2290 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1: Change
At the time of use, it meets the requirements for Constituted Solutions under Labeling under Injections <1>.
to:
At the time of use, it meets the requirements for Constituted Solutions under Injections <1>.
ERGOTAMINE TARTRATE Identification USP37–NF32 2826 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 4:Change
value as the principal spot of Standard solution A.
to:
values as the corresponding spots of the Standard preparation.
LEVOTHYROXINE SODIUM TABLETS IMPURITIES/Organic Impurities/Procedure: Limit of Liothyronine Sodium USP37–NF32 3548 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 1 of Acceptance criteria: Change
NMT 2.0% of liothyronine
to:
NMT 2.0% of liothyronine sodium
VITAMIN E IDENTIFICATION/A./Sample solutions USP37–NF32 5163 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Lines 4 and 7 of Alpha tocopheryl acetate: Change
dilute sulfuric acid
to:
diluted sulfuric acid
CEFADROXIL CAPSULES ADDITIONAL REQUIREMENTS/USP Reference Standards <11> First Supplement to USP37–NF32 6604 1-Aug-2014 USP39–NF34 First Supplement to USP38–NF33 Line 2 of USP Cefadroxil Related Compound I RS: Change
(6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate.
to:
(6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido… Read More